Healthy VolunteersPhase 1NCT07570992
A Research Study to Evaluate the Safety of NNC1679-0001 When Given to Healthy Participants and Participants With T2DM
A Phase 1 study testing NNC1679-0001 in people with Healthy Volunteers and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Austria.
Trial summary
This study is testing a new medicine that might help treat people with type 2 diabetes. The purpose of the study is to see if the new study medicine is safe and how well is tolerated by the body. There will be two groups of participants in this study: healthy participants and participants with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Diabetes Mellitus, Type 2
- What is being tested?
- NNC1679-0001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteAustria
- Study dates
- 4 May 2026to 25 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine eligibility for the study.
- Male or female (sex at birth) of nonchildbearing potential.
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Healthy participants
- Body mass index (BMI) 18.5-29.9 kilograms per square meter (kg/m^2) (both inclusive) at screening.
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- Glycated haemoglobin (HbA1c) lesser than or equal to (<=) 6.4 percent (%) (47 [millimoles per mole] mmol/mol) at screening.
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiograms (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.
- Participants with Type 2 Diabetes Mellitus (T2DM)
- BMI 20.0-34.9 kg/m^2 (both inclusive) at screening.
- HbA1c 6.5-9.0% (47.5-74.9 mmol/mol) at screening.
- Diagnosed with T2DM greater than or equal to (>=)180 days before screening.
- Stable (as judged by the investigator) daily dose(s) of metformin or combination of metformin and dipeptidyl peptidase IV (DPP-4) inhibitors and/or sodium-glucose co-transport 2 SGLT 2) inhibitors >= 90 days before screening.
Who cannot join
- All participants
- Screening alanine aminotransferase (ALT) values greater than (>) upper limit of normal (ULN) +10%, aspartate aminotransferase (AST) values >ULN +20%, or total bilirubin >ULN.
- Renal impairment, defined as estimated glomerular filtration rate (eGFR) <60.0 milliliter per minute per 1.73 square meter (mL/min/1.73m^2), at screening.
- Clinical evidence of chronic kidney disease (CKD) and/or urinary albumin: creatinine ratio (UACR) >30 milligrams per gram (mg/g).
- Presence or history of cardiovascular disease, including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias, or clinically significant conduction disorders.
- Healthy participants
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- Any disorder that, in the investigator's opinion, might jeopardise participants' safety or compliance with the protocol.
- Supine blood pressure at screening outside the range of 90-139 millimeters of mercury (mmHg) for systolic or 50-89 mmHg for diastolic.
- Participants with T2DM
- Any disorder except for mild conditions under stable treatment associated with T2DM, which in the investigator's opinion might jeopardise participant safety or compliance with the protocol.
- Supine blood pressure at screening outside the range of 90-159 mmHg for systolic or 50-99 mmHg for diastolic. This exclusion criterion also pertains to those participants who are receiving antihypertensive treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1,Double-blinded,Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of NNC1679-0001 When Administered to Healthy Participants and Participants With T2DM
This study is testing a new medicine that might help treat people with type 2 diabetes. The purpose of the study is to see if the new study medicine is safe and how well is tolerated by the body. There will be two groups of participants in this study: healthy participants and participants with type 2 diabetes. Participant will either get study medicine (NNC1679-0001) or placebo (a treatment that has no active medicine in it). NNC1679-0001 is a new experimental medicine that doctors cannot prescribe yet. Which treatment the participant gets is decided by chance. Participant will get one dose which will be injected into the area around abdomen (belly) by the medical staff.
- Conditions
- Healthy Volunteers, Diabetes Mellitus, Type 2
- Being tested
- NNC1679-0001, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC1679-0001Drug
NNC1679-0001 will be administered subcutaneously.
PlaceboDrug
Placebo will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| NNC1679-0001 | Experimental | Participants will receive NNC1679-0001 subcutaneously. Receives: Drug: NNC1679-0001 |
| Placebo | Placebo comparator | Participants will receive placebo matched to NNC1679-0001 s.c. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-Emergency Adverse Events (TEAEs)
Measured in events.
Measured: From dosing (day 1) upto week 34
Secondary outcomes (7)
Number of TEAEs
Measured in events.
Measured: From dosing (day 1) until V15a/V15b (week 26)
Number of hypoglycaemic episodes
Measured in episodes.
Measured: From dosing (day 1) upto week 34
AUC: The area under the NNC1679-0001 plasma concentration-time curve from time zero to the last measurable concentration after a single dose
Measured in hours*nanograms per milliliter (hour × ng/mL).
Measured: From dosing (day 1) upto day 3 or day 15
Cmax: The maximum concentration of NNC1679-0001 in plasma after a single dose
Measured in nanograms per milliliter (ng/mL).
Measured: From dosing (day 1) upto day 3 or day 15
tmax: The time from dosing to maximum plasma concentration of NNC1679-0001 after a single dose
Measured in hours.
Measured: From dosing (day 1) upto day 3 or day 15
t1/2: Terminal half-life for NNC1679-0001 after a single dose
Measured in hours.
Measured: From dosing (day 1) upto day 3 or day 15
CLR: Renal clearance of NNC1679-0001 after a single dose
Measured in liter per hours (L/hours).
Measured: From dosing (day 1) upto day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start4 May 2026
- Primary completion25 Jun 2028 (estimated)
- Study completion25 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency dept. 2834, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570992
- Sponsor's protocol ID
- NN1679-8505
- Other IDs
- U1111-1329-6912, 2025-523304-68, 2025
- Status last verified
- Jun 2026
- First submitted
- 30 Apr 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1,Double-blinded,Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of NNC1679-0001 When Administered to Healthy Participants and Participants With T2DM
- ClinicalTrials.gov ID
- NCT07570992
- Acronym / sponsor ID
- NN1679-8505
- Conditions
- Healthy Volunteers, Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 4 May 2026 (actual)
- Primary completion
- 25 Jun 2028 (estimated)
- Study completion
- 25 Jun 2028 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is testing a new medicine that might help treat people with type 2 diabetes. The purpose of the study is to see if the new study medicine is safe and how well is tolerated by the body. There will be two groups of participants in this study: healthy participants and participants with type 2 diabetes. Participant will either get study medicine (NNC1679-0001) or placebo (a treatment that has no active medicine in it). NNC1679-0001 is a new experimental medicine that doctors cannot prescribe yet. Which treatment the participant gets is decided by chance. Participant will get one dose which will be injected into the area around abdomen (belly) by the medical staff.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC1679-0001 | Experimental | Drug: NNC1679-0001Participants will receive NNC1679-0001 subcutaneously. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo matched to NNC1679-0001 s.c. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- All participants
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine eligibility for the study.
- Male or female (sex at birth) of nonchildbearing potential.
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Healthy participants
Key exclusion criteria (11 listed)
- All participants
- Screening alanine aminotransferase (ALT) values greater than (>) upper limit of normal (ULN) +10%, aspartate aminotransferase (AST) values >ULN +20%, or total bilirubin >ULN.
- Renal impairment, defined as estimated glomerular filtration rate (eGFR) <60.0 milliliter per minute per 1.73 square meter (mL/min/1.73m^2), at screening.
- Clinical evidence of chronic kidney disease (CKD) and/or urinary albumin: creatinine ratio (UACR) >30 milligrams per gram (mg/g).
- Presence or history of cardiovascular disease, including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias, or clinically significant conduction disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC1679-0001NNC1679-0001 will be administered subcutaneously. | Drug | NNC1679-0001 |
| PlaceboPlacebo will be administered subcutaneously. | Drug | Placebo |
Primary outcome
Number of Treatment-Emergency Adverse Events (TEAEs)
Time frame: From dosing (day 1) upto week 34
Measured in events.
7 secondary outcomes
Number of TEAEs
Time frame: From dosing (day 1) until V15a/V15b (week 26)
Number of hypoglycaemic episodes
Time frame: From dosing (day 1) upto week 34
AUC: The area under the NNC1679-0001 plasma concentration-time curve from time zero to the last measurable concentration after a single dose
Time frame: From dosing (day 1) upto day 3 or day 15
Cmax: The maximum concentration of NNC1679-0001 in plasma after a single dose
Time frame: From dosing (day 1) upto day 3 or day 15
tmax: The time from dosing to maximum plasma concentration of NNC1679-0001 after a single dose
Time frame: From dosing (day 1) upto day 3 or day 15
t1/2: Terminal half-life for NNC1679-0001 after a single dose
Time frame: From dosing (day 1) upto day 3 or day 15
CLR: Renal clearance of NNC1679-0001 after a single dose
Time frame: From dosing (day 1) upto day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Transparency dept. 2834 study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC1679-0001 in people with Healthy Volunteers and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment-Emergency Adverse Events (TEAEs) (time frame: From dosing (day 1) upto week 34). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.